Lenvatinib for the treatment of kidney cancer

References

• Yagoda A, Petrylak D, Thompson S. Cytotoxic chemotherapy for advanced renal cell carcinoma. Urol Clin North Am. 1993;20:303–321.
   PubMed Web of Science ®Google Scholar
• Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet. 1999;353:14–17.
   PubMed Web of Science ®Google Scholar
• Pyrhonen S, Salminen E, Ruutu M, et al. Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol. 1999;17:2859–2867.
   PubMed Web of Science ®Google Scholar
• Fyfe G, Fisher RI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13:688–696.
   PubMed Web of Science ®Google Scholar
• McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005;23:133–141.
   PubMed Web of Science ®Google Scholar
• Brugarolas J. Renal-cell carcinoma – molecular pathways and therapies. N Engl J Med. 2007 Jan;356(2):185–187. PubMed PMID: WOS:000243373700014.
   PubMed Web of Science ®Google Scholar
• Rini BI, Halabi S, Rosenberg JE, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010;28:2137–2143.
   PubMed Web of Science ®Google Scholar
• Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370:2103–2111.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356:115–124.
   PubMed Web of Science ®Google Scholar
• Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28:1061–1068.
   PubMed Web of Science ®Google Scholar
• Buchler T, Bortlicek Z, Poprach A, et al. Outcomes for patients with metastatic renal cell carcinoma achieving a complete response on targeted therapy: a registry-based analysis. Eur Urol. 2016 Sep;70(3):469–475. PubMed PMID: WOS:000380754000024.
   PubMed Web of Science ®Google Scholar
• Buchler T, Poprach A, Bortlicek Z, et al. Outcomes of patients with long-term treatment response to vascular endothelial growth factor-targeted therapy for metastatic renal cell cancer. Clin Genitourin Cancer. 2017 Dec;15(6):E1047–E1053. PubMed PMID: WOS:000417112200017.
   PubMed Web of Science ®Google Scholar
• Buchler T, Klapka R, Melichar B, et al. Sunitinib followed by sorafenib or vice versa for metastatic renal cell carcinoma – data from the Czech registry. Ann Oncol. 2012;23:395–401.
   PubMed Web of Science ®Google Scholar
• Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011;144:646–674.
   PubMed Web of Science ®Google Scholar
• Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356:2271–2281.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase iii trial. J Clin Oncol. 2013 Oct;31(30):3791–3799. PubMed PMID: WOS:000330540400016.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017 Feb;35(6):591–597. PubMed PMID: WOS:000394450900005.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372:449–456.
   PubMed Web of Science ®Google Scholar
• Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011;378:1931–1939.
   PubMed Web of Science ®Google Scholar
• Campone M, Bachelot T, Gnant M, et al. Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: subgroup analysis from the BOLERO-2 study. Eur J Cancer. 2013 Aug;49(12):2621–2632. PubMed PMID: WOS:000321336800002.
   PubMed Web of Science ®Google Scholar
• Beck JT, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane as first-line therapy in HR+, HER2(-) advanced breast cancer in BOLERO-2. Breast Cancer Res Treat. 2014 Feb;143(3):459–467. PubMed PMID: WOS:000330973700005.
   PubMed Web of Science ®Google Scholar
• Studentova H, Vitaskova D, Melichar B. Safety of mTOR inhibitors in breast cancer. Expert Opin Drug Saf. 2016 Aug;15(8):1075–1085. PubMed PMID: WOS:000381534600009.
   PubMed Web of Science ®Google Scholar
• Ravaud A, Barrios CH, Alekseev B, et al. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378–1384. PubMed PMID: WOS:000358170400016.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015 Nov;373(19):1803–1813. PubMed PMID: WOS:000364144000004.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Glen H, et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov;16(15):1473–1482. PubMed PMID: WOS:000364470900030.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015 Nov;373(19):1814–1823. PubMed PMID: WOS:000364144000005.
   PubMed Web of Science ®Google Scholar
• Karaman MW, Herrgard S, Treiber DK, et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008 Jan;26(1):127–132. PubMed PMID: 18183025; eng.
   PubMed Web of Science ®Google Scholar
• Matsui J, Funahashi Y, Uenaka T, et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res. 2008 Sep 1;14(17):5459–5465. PubMed PMID: 18765537; eng.
   PubMed Web of Science ®Google Scholar
• Matsui J, Yamamoto Y, Funahashi Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer. 2008 Feb 1;122(3):664–671. PubMed PMID: 17943726; eng.
   PubMed Web of Science ®Google Scholar
• Okamoto K, Kodama K, Takase K, et al. Antitumor activities of the targeted multi-tyrosine kinase inhibitor lenvatinib (E7080) against RET gene fusion-driven tumor models. Cancer Lett. 2013 Oct 28;340(1):97–103. PubMed PMID: 23856031; eng.
   PubMed Web of Science ®Google Scholar
• Matsui J, Funahashi Y, Uenaka T, et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res. 2008 Sep;14(17):5459–5465. PubMed PMID: WOS:000259166000018.
   PubMed Web of Science ®Google Scholar
• Matsui J, Yamamoto Y, Funahashi Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer. 2008 Feb;122(3):664–671. PubMed PMID: WOS:000252132900027.
   PubMed Web of Science ®Google Scholar
• Negrier S, Gravis G, Perol D, et al. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. Lancet Oncol. 2011;12:673–680.
   PubMed Web of Science ®Google Scholar
• Flaherty KT, Manola JB, Pins M, et al. Best: a randomized phase ii study of vascular endothelial growth factor, Raf kinase, and mammalian target of rapamycin combination targeted therapy with bevacizumab, sorafenib, and temsirolimus in advanced renal cell carcinoma trial of the ECOG-ACRIN cancer research group (E2804). J Clin Oncol. 2015 Jul;33(21):2384–U88. PubMed PMID: WOS:000361653900010.
   PubMed Web of Science ®Google Scholar
• Rini BI, Bellmunt J, Clancy J, et al. Randomized phase iii trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar;32(8):752–759. PubMed PMID: WOS:000332483400011.
   PubMed Web of Science ®Google Scholar
• Okamoto K, Ikemori-Kawada M, Jestel A, et al. Distinct binding mode of multikinase inhibitor lenvatinib revealed by biochemical characterization. ACS Med Chem Lett. 2015 Jan;6(1):89–94. PubMed PMID: WOS:000347742200024.
   PubMed Web of Science ®Google Scholar
• Straussman R, Morikawa T, Shee K, et al. Tumour micro-environment elicits innate resistance to RAF inhibitors through HGF secretion. Nature. 2012 Jul 26;487(7408):500–504. PubMed PMID: 22763439; PubMed Central PMCID: PMCPMC3711467. eng.
   PubMed Web of Science ®Google Scholar
• Dieci MV, Arnedos M, Andre F, et al. Fibroblast growth factor receptor inhibitors as a cancer treatment: from a biologic rationale to medical perspectives. Cancer Discov. 2013 Mar;3(3):264–279. PubMed PMID: 23418312; eng.
   PubMed Web of Science ®Google Scholar
• Tohyama O, Matsui J, Kodama K, et al. Antitumor activity of lenvatinib (e7080): an angiogenesis inhibitor that targets multiple receptor tyrosine kinases in preclinical human thyroid cancer models. J Thyroid Res. 2014;2014:638747. PubMed PMID: 25295214; PubMed Central PMCID: PMCPMC4177084. eng.
   PubMedGoogle Scholar
• Turner N, Grose R. Fibroblast growth factor signalling: from development to cancer. Nat Rev Cancer. 2010 Feb;10(2):116–129. PubMed PMID: 20094046; eng.
   PubMed Web of Science ®Google Scholar
• Korc M, Friesel RE. The role of fibroblast growth factors in tumor growth. Curr Cancer Drug Targets. 2009 Aug;9(5):639–651. PubMed PMID: 19508171; PubMed Central PMCID: PMCPMC3664927. eng.
   PubMed Web of Science ®Google Scholar
• Matsuki M, Adachi Y, Ozawa Y, et al. Targeting of tumor growth and angiogenesis underlies the enhanced antitumor activity of lenvatinib in combination with everolimus. Cancer Sci. 2017 Apr;108(4):763–771. PubMed PMID: WOS:000400574700026.
   PubMed Web of Science ®Google Scholar
• Ikuta K, Yano S, Trung VT, et al. E7080, a multi-tyrosine kinase inhibitor, suppresses the progression of malignant pleural mesothelioma with different proangiogenic cytokine production profiles. Clin Cancer Res. 2009 Dec;15(23):7229–7237. PubMed PMID: WOS:000272363700017.
   PubMed Web of Science ®Google Scholar
• Yamada K, Yamamoto N, Yamada Y, et al. Phase I dose-escalation study and biomarker analysis of e7080 in patients with advanced solid tumors. Clin Cancer Res. 2011 Apr;17(8):2528–2537. PubMed PMID: WOS:000289555500048.
   PubMed Web of Science ®Google Scholar
• Boss DS, Glen H, Beijnen JH, et al. A phase I study of E7080, a multitargeted tyrosine kinase inhibitor, in patients with advanced solid tumours. Br J Cancer. 2012 May;106(10):1598–1604. PubMed PMID: WOS:000303823400005.
   PubMed Web of Science ®Google Scholar
• Gupta A, Jarzab B, Capdevila J, et al. Population pharmacokinetic analysis of lenvatinib in healthy subjects and patients with cancer. Br J Clin Pharmacol. 2016 Jun;81(6):1124–1133. PubMed PMID: WOS:000382508500013.
   PubMed Web of Science ®Google Scholar
• Dubbelman AC, Rosing H, Nijenhuis C, et al. Pharmacokinetics and excretion of C-14-lenvatinib in patients with advanced solid tumors or lymphomas. Invest New Drugs. 2015 Feb;33(1):233–240. PubMed PMID: WOS:000347949400025.
   PubMed Web of Science ®Google Scholar
• Hussein Z, Mizuo H, Hayato S, et al. Clinical pharmacokinetic and pharmacodynamic profile of lenvatinib, an orally active, small-molecule, multitargeted tyrosine kinase inhibitor. Eur J Drug Metab Pharmacokinet. 2017 Dec;42(6):903–914. PubMed PMID: WOS:000415247600003.
   PubMed Web of Science ®Google Scholar
• Molina AM, Hutson TE, Larkin J, et al. A phase 1b clinical trial of the multi-targeted tyrosine kinase inhibitor lenvatinib (E7080) in combination with everolimus for treatment of metastatic renal cell carcinoma (RCC). Cancer Chemother Pharmacol. 2014 Jan;73(1):181–189. PubMed PMID: WOS:000329223200021.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Ren M, et al. Independent assessment of lenvatinib plus everolimus in patients with metastatic renal cell carcinoma. Lancet Oncol. 2016 Jan;17(1):E4–E5. PubMed PMID: WOS:000367099700005.
   PubMed Web of Science ®Google Scholar
• Nair A, Lemery SJ, Yang J, et al. FDA approval summary: lenvatinib for progressive, radio-iodine-refractory differentiated thyroid cancer. Clin Cancer Res. 2015 Dec;21(23):5205–5208. PubMed PMID: WOS:000365603800005.
   PubMed Web of Science ®Google Scholar
• Lee CH, Makker V, Rasco D, et al. A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with renal cell carcinoma. Ann Oncol. 2017 Sep; 28. Suppl. 5, 8470. PubMed PMID: WOS:000411324002038.
   Google Scholar
• Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. New Engl J Med. 2018 Apr 5;378(14):1277–1290. PubMed PMID: 29562145; eng.
   PubMed Web of Science ®Google Scholar
• Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125–134.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Rini BI, Bukowski RM, et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006;295:2516–2524.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Barrios CH, Kim TM, et al. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Sep 1;32(25):2765–2772. PubMed PMID: 25049330; PubMed Central PMCID: PMCPMC5569681. eng.
   PubMed Web of Science ®Google Scholar
• Knox JJ, Barrios CH, Kim TM, et al. Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC. Ann Oncol. 2017 Jun 1;28(6):1339–1345. PubMed PMID: 28327953; PubMed Central PMCID: PMCPMC5452072. eng.
   PubMed Web of Science ®Google Scholar
• Pizzocaro G, Piva L, Colavita M, et al. Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study. J Clin Oncol. 2001;19:425–431.
   PubMed Web of Science ®Google Scholar
• Haas NB, Manola J, Uzzo RG, et al. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016 May;387(10032):2008–2016. PubMed PMID: WOS:000375881500029.
   PubMed Web of Science ®Google Scholar
• Ravaud A, Motzer RJ, Pandha HS, et al. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016 Dec;375(23):2246–2254. PubMed PMID: WOS:000389310000007.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Haas NB, Donskov F, et al. Randomized phase iii trial of adjuvant pazopanib versus placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma. J Clin Oncol. 2017 Dec;35(35):3916–3923. PubMed PMID: WOS:000417565500005.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Mazumdar M, Bacik J, et al. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17:2530–2540.
   PubMed Web of Science ®Google Scholar
• Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009 Dec 1;27(34):5794–5799. PubMed PMID: 19826129; eng.
   PubMed Web of Science ®Google Scholar
• Melichar B. Laboratory medicine and medical oncology: the tale of two Cinderellas. Clin Chem Lab Med. 2013;51:99–112.
   PubMed Web of Science ®Google Scholar
• Melichar B, Nemcová I. Eye complications of cetuximab therapy. Eur J Cancer Care. 2007;16:439–443.
   PubMed Web of Science ®Google Scholar
• Poprach A, Pavlik T, Melichar B, et al. Skin toxicity and efficacy of sunitinib and sorafenib in metastatic renal cell carcinoma: a national registry-based study. Ann Oncol. 2012;23(12):3137–3143.
   PubMed Web of Science ®Google Scholar
• Rini BI, Melichar B, Fishman MN, et al. Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1372–1377. PubMed PMID: WOS:000358170400015.
   PubMed Web of Science ®Google Scholar
• Donskov F, Michaelson MD, Puzanov I, et al. Sunitinib-associated hypertension and neutropenia as efficacy biomarkers in metastatic renal cell carcinoma patients. Br J Cancer. 2015 Dec 1;113(11):1571–1580. PubMed PMID: 26492223; PubMed Central PMCID: PMCPmc4705883. eng.
   PubMed Web of Science ®Google Scholar
• Rautiola J, Donskov F, Peltola K, et al. Sunitinib-induced hypertension, neutropaenia and thrombocytopaenia as predictors of good prognosis in patients with metastatic renal cell carcinoma. BJU International. 2016 Jan;117(1):110–117. PubMed PMID: 25252180; eng.
   PubMed Web of Science ®Google Scholar
• Soerensen AV, Geertsen PF, Christensen IJ, et al. A five-factor biomarker profile obtained week 4-12 of treatment for improved prognostication in metastatic renal cell carcinoma: results from DARENCA study 2. Acta Oncol. 2016;55(3):341–348. PubMed PMID: 26449266; PubMed Central PMCID: PMCPmc4819832. eng.
   PubMed Web of Science ®Google Scholar
• Penttila P, Donskov F, Rautiola J, et al. Everolimus-induced pneumonitis associates with favourable outcome in patients with metastatic renal cell carcinoma. Eur J Cancer. 2017 Aug;81:9–16. PubMed PMID: 28586749; eng.
   PubMed Web of Science ®Google Scholar
• Freedman RS, Vadhan-Raj S, Butts C, et al. Pilot study of Flt3 ligand comparing intraperitoneal with subcutaneous routes on hematologic and immunologic responses in patients with peritoneal carcinomatosis and mesotheliomas. Clin Cancer Res. 2003;9:5228–5237.
   PubMed Web of Science ®Google Scholar
• Zezulova M, Bartouskova M, Hlidkova E, et al. Citrulline as a biomarker of gastrointestinal toxicity in patients with rectal carcinoma treated with chemoradiation. Clin Chem Lab Med. 2016;54:305–314.
   PubMed Web of Science ®Google Scholar
• Melichar B, Studentová H, Kalabova H, et al. Predictive and prognostic significance of tumor-infiltrating lymphocytes in patients with breast cancer treated with neodjuvant systemic therapy. Anticancer Res. 2014;34:1115–1126.
   PubMed Web of Science ®Google Scholar